Use of an Integrated Orthotic and Rehabilitation Initiative for Treatment of Lower Extremity Musculoskeletal Disorders

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05780502
Status
Recruiting
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Conditions

  • Musculoskeletal Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Passive Dynamic Brace — BEHAVIORAL
    Patient receiving the Passive Dynamic Brace

Study Details

The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom, energy storage and return ankle orthosis proven to improve functional ability when coupled with a customized high-intensity rehabilitation program. The Return to Performance (RTP) clinical pathway is the civilian version of the evidence-based Return To Run (RTR) clinical pathway. Together, the CUSTOMIZED EXOSKELETAL ORTHOSIS and RTP form a novel orthotic and rehabilitation initiative. A diverse group of patients has utilized the pathway to date, including combat wounded Soldiers undergoing complex limb salvage procedures, those with muscle and tendon deficiencies, patients with postoperative nerve palsies, various lower extremity fractures and many others. With this study we are seeking to determine how participation in CUSTOMIZED EXOSKELETAL ORTHOSIS RTP clinical pathway affects patient outcomes as determined by validated functional outcome measures. Subjects will undergo testing before, during and after completion of the clinical pathway.

Key Dates

Start date
May 6, 2015
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
370 participants (estimated)

Primary Outcome Measure

Change in patient-reported outcomes measurement information system (PROMIS 29) scores [ Time Frame: baseline, week 0 (time of delivery), 3, 6, 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carolinas Medical CenterCharlotteNorth Carolina28203
Rachel B Seymour, PhD
Christine Churchill, MA
Joseph R Hsu, MD (PRINCIPAL_INVESTIGATOR)
Rachel B Seymour, PhD (SUB_INVESTIGATOR)
Michael Bosse, MD (SUB_INVESTIGATOR)
Madhav Karunakar, MD (SUB_INVESTIGATOR)
Chris Adair, MD (SUB_INVESTIGATOR)

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By research site
Carolinas Medical Center· Charlotte, NC

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